EUS-guided FNB-induced PANCREatitis Assessment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Tehran
About this trial
This is a descriptive analytical study to investigate the prevalence and risk factors for pancreatitis after Endoscopic Ultrasonography-guided Fine Needle Biopsy (EUS-FNB) in patients at Shariati Hospital in Tehran. The study aims to identify risk factors for post-FNB pancreatitis to improve clinical protocols, reduce complications and treatment costs, and increase diagnostic accuracy for pancreatic and biliary tract diseases. The study will collect demographic and clinical data from all eligible patients undergoing EUS-guided FNB during the study period. Amylase and lipase levels will be measured in all enrolled patients 24 hours post-procedure. Pancreatitis will be diagnosed based on abdominal pain and amylase or lipase levels exceeding three times the normal range 24 hours after the procedure. The outcomes will be independently adjudicated by an expert gastroenterologist not involved in the EUS procedures by reviewing participants' medical records. The consensus definition will be applied as a diagnostic framework (rather than a strict definition) so that the adjudicator can use their best judgment in cases that does not strictly satisfy the criteria. The patients will be contacted 24-72 h after the procedure to follow-up on any potential complications. The study plans to enroll at least 300 patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pancreas
Ampulla of Vater
Distal CBD, defined as the intrapancreatic portion of the CBD where the FNB needle passes through the pancreas during biopsy
Disqualifiers
Patients who undergo concurrent ERCP in the same day
Patients experiencing an ongoing episode of acute pancreatitis during EUS-FNB
Patients undergoing EUS-guided FNA
Uncorrectable coagulopathy (INR > 1.5)
Trial population
Consecutive inpatients and outpatients aged 18 years or older undergoing EUS-guided FNB at Shariati Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
EUS-guided FNB
DeviceEUS-guided FNB from the lesions in the pancreatobiliary tract
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Incidence of Post-EUS-FNB acute pancreatitis
Determining the incidence of acute pancreatitis after EUS-guided FNB from the pancreatobiliary lesions
Time frame
From enrollment to three days after EUS-FNBSecondary outcomes
1
Factors associated with post-EUS-FNB pancreatitis
The secondary objectives are to determine the role of the following factors in the development of pancreatitis after EUS-guided FNB: * Gender * Age * Biopsy site * Dilation of the main pancreatic duct (PD) and common bile duct (CBD) * The amount of normal pancreatic tissue the needle passes through * Number of needle passes * Number of back and forth movement of the needle in each pass * Biopsy approach (transgastric or transduodenal) * History of pancreatitis * Type of lesion (solid vs. cystic) * Needle size
Time frame
From enrollment to three days after EUS-FNB2
Incidence of moderate to severe post-FNB pancreatitis
The incidence of moderate to severe post-FNB pancreatitis will be assessed using Atlanta classification.
Time frame
From enrollment to one week after EUS-FNBSponsors and contacts
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Source ClinicalTrials.gov